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Using Genomic Analysis to Guide Individual Treatment in Glioblastoma

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ClinicalTrials.gov Identifier: NCT02725684
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : October 25, 2017
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Lenox Hill Hospital
North Shore University Hospital
NYU Langone Health
Weill Medical College of Cornell University
Albert Einstein College of Medicine
New York Genome Center
Information provided by (Responsible Party):
Rockefeller University

Brief Summary:
The purpose of this study is to assess whether the use of genomics can help identify patient specific treatment choices in cancer. In order to test this, the investigators plan to use genomic sequencing technology to identify patient specific mutations in glioblastoma multiforme (GBM) as compared to normal cells to identify mutations. Further analysis will identify potential treatment targets and whether there are any drugs that could be used for these particular mutations. Follow up clinical data will be assessed to see if this individualized method of choosing treatment options can improve clinical outcomes in patients with GBM.

Condition or disease Intervention/treatment
Glioblastoma Other: Observational study, no intervention

Detailed Description:

The purpose of the study is to assess whether the use of genomics can identify patient specific treatment choices in glioblastoma (GBM) that improves clinical outcomes over standard of care. GBM is a devastating disease, the most common primary brain tumor and the most aggressive. With current standard therapy, which includes surgery, radiation therapy, and chemotherapy with temozolomide, the median survival is only 14.6 months. Once patients fail temozolomide, there are no other proven therapies, although other chemotherapies, bevacizumab, and tyrosine kinase inhibitors are often tried. Because tumors are different between patients, outcomes vary among patients. For example, temozolomide, though recommended to all patients with GBM as the only chemotherapy to improve survival, is also known not to be effective in patients with o6-methylguanine-DNA-methyltransferase (MGMT) unmethylated tumors. This example underscores the idea that if each tumor is different, and that perhaps there would be better outcomes if each tumor was treated uniquely.

Genomic sequencing is a technology that can be employed to identify specific characteristics of each tumor as compared to healthy cells. Since 2008, genomic sequencing technology has advanced significantly, having entered the era of next generation sequencing, and simultaneously, the cost of using this technology has dramatically decreased, nearing the cost of some currently used diagnostic tests such as MRI. In this study, the investigators plan to assess the usefulness of this technology and its analysis as a method of guiding treatment choices for the individual patient with GBM.

The investigators plan to sequence tumor/normal from GBM patients to identify mutations. The mutations will be analyzed for potential drug targets for treatment and recommendations for treatment will be suggested if any are identified. If the clinician implements the recommendations, clinical follow up data will be collected. The investigators will compare clinical outcomes, such as survival to historical controls undergoing standard of care treatment to assess whether this genomic guided, individualized therapy determination improves these measures.

In addition, the investigators plan to use next generation sequencing methods to determine whether the presence of brain messenger ribonucleic acid (mRNA) and miRNA can be detected in the peripheral blood and whether there is biological relevance to their presence if detected.


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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Genomic Analysis to Guide Individual Treatment in Glioblastoma
Actual Study Start Date : March 12, 2015
Actual Primary Completion Date : July 7, 2017
Actual Study Completion Date : July 7, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Glioblastoma
Observational study, no intervention
Other: Observational study, no intervention
Observational study, no intervention




Primary Outcome Measures :
  1. Identification of targetable variants in the tumor [ Time Frame: 6 months ]
    Identification of variants in each tumor that are potential drug targets


Biospecimen Retention:   Samples With DNA
Unused samples retained


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with glioblastoma
Criteria

Inclusion Criteria:

  • Histologically confirmed glioblastoma multiforme
  • Enough tumor tissue available from initial surgery to obtain at least 5 ug DNA and 5 ug RNA
  • Sufficient blood sample to obtain 5 ug DNA and 5 ug RNA
  • Karnofsky score at least 60
  • Life expectancy at least 6 months

Exclusion Criteria:

  • Subjects not interested in further treatment of their brain tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725684


Locations
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United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10017
Rockefeller University
New York, New York, United States, 10065
Weill Cornell Medical College
New York, New York, United States, 10065
Lenox Hill Hospital
New York, New York, United States, 10075
North Shore University Hospital
New York, New York, United States, 11030
Montefiore Medical Center
The Bronx, New York, United States, 10467
Sponsors and Collaborators
Rockefeller University
Memorial Sloan Kettering Cancer Center
Lenox Hill Hospital
North Shore University Hospital
NYU Langone Health
Weill Medical College of Cornell University
Albert Einstein College of Medicine
New York Genome Center
Investigators
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Principal Investigator: Robert Darnell, MD, PhD Rockefeller University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT02725684     History of Changes
Other Study ID Numbers: RDA-0837
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be coded and shared with members of the collaboration.

Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue